BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE

    MDR report key: 1874312 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00445
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K041399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT WAS RETURNED TO MFG FACILITY FOR EVAL. THE RETURNED DEVICE WAS EXAMINED: THE PROTECTIVE DEVICE WAS SEATED FIRMLY ON THE SYRINGE LUER AS PER PRODUCT SPECIFICATIONS; HOWEVER, THE NEEDLE WAS BENT AT A 45 DEGREE ANGLE ORIGINATING AT THE HUB. THE NEEDLE WAS RELEASED FROM THE CAPTURE DEVICE AND STRAIGHTENED. THE NEEDLE EASILY SNAPPED INTO THE RETAINING CLIPS. THE LUER TAPERS WERE BOTH MEASURED AND FOUND TO MEET WITH TAPER GAUGE TESTING. OUR EVAL WAS UNABLE TO DETERMINE ROOT CAUSE AND WE WERE UNABLE TO DETERMINE HOW OR WHEN THE DEVICE BECAME BENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THAT THE CANNULA OF THE NEEDLE WAS BENT, IT WAS NOT FULLY CAPTURED IN THE SAFETY DEVICE AND WAS EXPOSED. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK